Pediatric Balloon Sinuplasty

Pediatric rhinosinusitis is common but sometimes overlooked. Pediatric patients are often subject to other disease entities which may have a significant overlap with symptoms associated with pediatric Chronic Rhinosinusitis (CRS).1-3

Symptom overlap examples include1-3:

Allergic rhinitis

Recurrent viral URI

Chronic adenoiditis

ET dysfunction

Currently there is a lack of evidence for antibiotic efficacy in chronic sinusitis.4 Adenoidectomy failure rate is 40-60% when used as a sole Chronic Rhinosinusitis (CRS) surgical treatment.5-6

The result is a considerable loss of school time and/or accumulation of medical expenses, affecting children and their parents.7

Balloon Sinuplasty, Safe and Effective for Children Suffering from Chronic Sinusitis

Adenoidectomy with Balloon Sinuplasty and lavage of the maxillary sinus may be an appropriate surgical therapy for children deemed to have failed medical treatment.1,8,9

Multiple studies have demonstrated long-term success of 80-87% with adenoidectomy or after failed adenoidectomy.8-11*

In one study, a higher percentage of children’s SN-5 sinonasal symptoms were improved at 12 months, in the Balloon Sinuplasty and adenoidectomy group (80%) compared to the group that underwent adenoidectomy alone (53%).9*

*Patients were not randomized between the Balloon Sinuplasty and adenoidectomy group and the adenoidectomy alone group. Therefore, the results may be due to different patient characteristics rather than the procedure performed.

Acclarent's Balloon Sinuplasty Systems (RELIEVA® SPIN and ULTIRRA®) are indicated for children aged 17 and under and are intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Balloon Sinuplasty is an Effective Option After Failed Adenoidectomy

In a tertiary care, university affiliated pediatric institution, a side-by-side post-operative comparison of patients who underwent Balloon Sinuplasty with ethmoidectomy or ESS after failed adenoidectomy was conducted. Although the difference was not statistically significant, 62.3% of ESS patients and 80% of Balloon Sinuplasty patients reported improvement in their overall sinus symptoms post-operatively.10**

**Patients were not randomized between the Balloon Sinuplasty and ESS group. Therefore, the results may be due to different patient characteristics rather than the procedure performed.

For Patients

OpenMyEars.com

Acclarent, Inc. has created a dedicated website for patients that provides valuable information about Eustachian tube dysfunction, its symptoms, and potential surgical options. You can direct your patients to the site to provide them with background so you and they can make informed choices.

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ACCLARENT® Balloon Sinuplasty Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. ACCLARENT® Balloon Sinuplasty Device use has described risks, including tissue and mucosal trauma, infection, or possible orbital injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices, as well as all products mentioned on this resource.

Caution: Federal (US) law restricts the sale, distribution or use of these devices to, by or on the order of a physician. Third party trademarks used herein are trademarks of their respective owners. This site is intended for visitors from the United States and published by Acclarent, Inc., which is solely responsible for its contents.

RELIEVA SPINPLUS® Balloon Sinuplasty System and RELIEVA ULTIRRA® Sinus Balloon Catheter are indicated for dilation of maxillary sinuses in children 17 and younger. All referenced studies below included limited use of the devices in frontal and sphenoid sinuses, for which the safety and effectiveness for children 17 and under has not been establised.